MAUDE Adverse Event Report: RADIOMETER MEDICAL APS TRANSCUTANEOUS BLOOD GAS MONITOR; TCM4 MONITORING SYS

Model Number TCM4 SERIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 04/01/2014

Event Type  Injury  

Event Description

The pt (a neonatal boy born in (b)(6) gestation week) received a burn mark on the right thigh.The temperature was set to 43 degrees celsius, and the electrode was placed on the same location for 7 hours.According to the operator's manual (tcm4/40 om page 6-12) the probe should be relocated after 4 hours at least.

Manufacturer Narrative

According to the complaint the temp of the sensor was set to 43 degrees celsius and the sensor was placed on the same location for 7 hrs.According to the operator's manual (tcm4/40 om page 6-12) the probe should be relocated after 4 hrs at least.A zero check on the sensor was performed and it passed fine.The temp was stable at 42.9 celsius so it was not an issue with the sensor.Additionally, the field service engineer completed the tcm4 complete alignment, and monitor performance test and everything passed fine.Since no error was identified on the unit or sensor, and it was stated that the sensor was not relocated every 4 hrs as it should be this case is suspected to be caused by a user error.

• Brand Name: TRANSCUTANEOUS BLOOD GAS MONITOR
• Type of Device: TCM4 MONITORING SYS
• Manufacturer (Section D): RADIOMETER MEDICAL APS; akandevej 21; bronshoj 2700 ; DA 2700
• Manufacturer Contact: akandevej 21; bronshoj 2700
• MDR Report Key: 3874109
• MDR Text Key: 4462349
• Report Number: 3002807968-2014-00017
• Device Sequence Number: 1
• Product Code: LKD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TCM4 SERIES
• Device Catalogue Number: 391-880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2014
• Initial Date FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other